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Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

Identifikátory výsledku

  • Kód výsledku v IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10366972" target="_blank" >RIV/00216208:11110/17:10366972 - isvavai.cz</a>

  • Nalezeny alternativní kódy

    RIV/00023728:_____/17:N0000035

  • Výsledek na webu

    <a href="http://dx.doi.org/10.1002/jbmr.3067" target="_blank" >http://dx.doi.org/10.1002/jbmr.3067</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1002/jbmr.3067" target="_blank" >10.1002/jbmr.3067</a>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

  • Popis výsledku v původním jazyce

    We present final results of a study comparing teriparatide 20g every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score-2.0 and 25OHD 9.2ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean +/- SD age: 77 +/- 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p&lt;0.001) and FN (+1.96% versus -1.19%; p=0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9s; p=0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3mm, p=0.033; -10.0 and -9.3mm at 12 and 26 weeks, respectively; p=0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p=0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. (c) 2016 American Society for Bone and Mineral Research.

  • Název v anglickém jazyce

    Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

  • Popis výsledku anglicky

    We present final results of a study comparing teriparatide 20g every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score-2.0 and 25OHD 9.2ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean +/- SD age: 77 +/- 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p&lt;0.001) and FN (+1.96% versus -1.19%; p=0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9s; p=0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3mm, p=0.033; -10.0 and -9.3mm at 12 and 26 weeks, respectively; p=0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p=0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. (c) 2016 American Society for Bone and Mineral Research.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30226 - Rheumatology

Návaznosti výsledku

  • Projekt

  • Návaznosti

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Ostatní

  • Rok uplatnění

    2017

  • Kód důvěrnosti údajů

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Údaje specifické pro druh výsledku

  • Název periodika

    Journal of Bone and Mineral Research

  • ISSN

    0884-0431

  • e-ISSN

  • Svazek periodika

    32

  • Číslo periodika v rámci svazku

    5

  • Stát vydavatele periodika

    US - Spojené státy americké

  • Počet stran výsledku

    12

  • Strana od-do

    1040-1051

  • Kód UT WoS článku

    000400590900017

  • EID výsledku v databázi Scopus

    2-s2.0-85018444254